Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

18-65 years old
smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
expired carbon monoxide reading of at least 15ppm
express a desire to quit smoking in the next 30 days

Exclusion Criteria:

Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
Hypotension (systolic <90 mm Hg, diastolic <60 mm Hg).
Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder (irregular heart rhythm);
Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
History of skin allergy;
Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
Liver or kidney disorder (except kidney stones, gallstones);
Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
Active ulcers in the past 30 days;
Lung disorder (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
History of migraine headaches in the past 5 years;
History of fainting;
Problems giving blood samples;
Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
Other major medical condition;
Current psychiatric disease (with the exception of anxiety disorders, Obsessive-compulsive disorder (OCD) and ADHD);
Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
Bulimia or anorexia;
Pregnant or nursing mothers;
Use (within the past 30 days) of:
Illegal drugs (or if the urine drug screen is positive),
Experimental (investigational) drugs;
Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse. Potential participants will be asked the first two questions on the AUDIT questionnaire during the phone screen. If the person scores "4" on both questions, a screening appointment will not be scheduled. During the screening session the entire AUDIT questionnaire will be administered. Females who score greater than or equal to 13 and males who score greater than or equal to 15 will be excluded from the study.
Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the past